EU → North America Device Access

SIC invent Sweden AB

SE-MF-000002493 · Sweden · Askim

SIC invent Sweden AB is registered in the European database on medical devices as a manufacturer, with 346 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa135
Class IIb211

Among these devices, 215 are declared sterile, 62 implantable.

Devices declared under this manufacturer

Showing 12 of 346 declared devices.

Catalogue references include 101113, 131146, 161463, 171035, 171185, 171209.

European nomenclature codes declared: P01020180, Q010399, P01020101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED346
Country of registrationSweden

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN346
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. SIC invent Sweden AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

All Sweden manufacturers →